Litigation Details for Almirall, LLC v. Amneal Pharmaceuticals LLC (D. Del. 2019)

Almirall, LLC v. Amneal Pharmaceuticals LLC (D. Del. 2019)

Docket		Date Filed	2019-04-09
Court	District Court, D. Delaware	Date Terminated	2022-05-23
Cause	35:271 Patent Infringement	Assigned To	Gerald J. Pappert
Jury Demand	None	Referred To
Parties	AMNEAL PHARMACEUTICALS LLC
Patents	9,161,926; 9,517,219
Attorneys	Samantha G. Wilson
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for Almirall, LLC v. Amneal Pharmaceuticals LLC (D. Del. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-04-09				External link to document
2019-04-09	4	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,517,219 B2. (myr) (Entered:… 2019 23 May 2022 1:19-cv-00658 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2019-04-09	10	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,161,926 B2 . (Gaza, Anne) (… 2019 23 May 2022 1:19-cv-00658 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2019-04-09	67	Stipulation of Dismissal	Dismissal of Counterclaims Relating to U.S. Patent No. 9,161,926 by Amneal Pharmaceuticals LLC. (Gaza, Anne… 2019 23 May 2022 1:19-cv-00658 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2019-04-09	156	Notice of Service	Osborne, Ph.D. Regarding Validity of U.S. Patent No. 9,517,219 filed by Almirall, LLC.(Raucci, Anthony)… 2019 23 May 2022 1:19-cv-00658 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2019-04-09	167	Order - -Memorandum and Order	Almirall sued Amneal in 2019, asserting U.S. Patent No. 9,517,219 in an attempt to stop Amneal from obtaining… I Almirall owns U.S. Patent No. 9,517,219, which covers ACZONE (dapsone) Gel, 7.5%…language of the claims of patent, the patent’s specification and the patent’s prosecution history (i.…the ’219 patent and the patent at issue in Geneva Pharms—infringement of the ’219 patent does not … A “[A] patent claim is that ‘portion of the patent document that defines the scope	External link to document
2019-04-09	189	Patent/Trademark Report to Commissioner of Patents	Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,517,219 B2 ; 9,161,926 B2. (smg) (… 2019 23 May 2022 1:19-cv-00658 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Litigation Summary and Analysis for Almirall, LLC v. Amneal Pharmaceuticals LLC

Background and Context

The litigation between Almirall, LLC and Amneal Pharmaceuticals LLC revolves around patent disputes related to Almirall's ACZONE Gel 7.5%, a prescription acne treatment containing dapsone. The patents in question are U.S. Patent Nos. 9,161,926 and 9,517,219, both listed in the Orange Book[3].

Initial Actions and Filings

• Amneal Pharmaceuticals filed Abbreviated New Drug Applications (ANDAs) with the FDA to market generic versions of ACZONE Gel 7.5%.
• To challenge the patents, Amneal petitioned the Patent Trial and Appeal Board (PTAB) for inter partes reviews (IPRs) of both the '926 and '219 patents[3].

District Court Litigation

• Almirall sued Amneal in the U.S. District Court for the District of Delaware, alleging infringement of the '219 patent. Amneal responded with a counterclaim seeking a declaratory judgment that the '926 patent is invalid and not infringed[2][3].

Settlement Negotiations and IPR Proceedings

• During settlement discussions between April 22 and 29, 2019, Almirall offered a covenant-not-to-sue on the '926 patent contingent on the dismissal of the IPR. However, the parties could not reach an agreement, and the IPR proceeded to trial on June 5, 2019[1][3].

PTAB Decision and Appeal

• The PTAB issued its final written decision on August 27, 2019, finding that claims 1–6 of the '926 patent were not unpatentable. Amneal appealed this decision to the Federal Circuit on October 28, 2019[1][3].

Voluntary Dismissal and Attorney Fees

• On March 30, 2020, Amneal filed a motion to voluntarily dismiss its appeal. Almirall agreed to the dismissal but sought reasonable attorney fees and costs incurred during the period from the end of settlement negotiations to the IPR trial date, as well as costs associated with defending against Amneal's motion to dismiss. The Federal Circuit denied Almirall's request for fees and costs, ruling that the conduct in question occurred before the appellate proceedings and did not meet the criteria for an exceptional case under 35 U.S.C. § 285[1][3].

Claim Construction and Indefiniteness

• In the district court, Amneal argued that the '219 patent was invalid due to indefiniteness, specifically regarding the term "polymeric viscosity builder" (PVB). Amneal contended that a person of ordinary skill in the art (POSA) could not determine whether the PVB satisfied the concentration requirements described in the claims. However, the court found that Amneal did not meet the clear and convincing evidence standard required to prove indefiniteness[2].

Obviousness and Negative Limitations

• In a related IPR, the PTAB and the Federal Circuit addressed the issue of obviousness regarding the '219 patent. Almirall argued that the claims were not obvious because they included a negative limitation excluding adapalene, another anti-acne agent. However, the Federal Circuit affirmed the PTAB's finding that the claims were obvious in view of the prior art, as the negative limitation did not distinguish the claims sufficiently[5].

Key Takeaways

• Settlement Negotiations: The failure to reach a settlement agreement led to continued litigation, highlighting the importance of clear communication and mutually acceptable terms in settlement discussions.
• IPR and PTAB Decisions: The PTAB's findings and the Federal Circuit's affirmations underscore the rigorous standards for proving unpatentability and the importance of clear claim language.
• Attorney Fees: The denial of attorney fees emphasizes that fees are awarded only in exceptional cases, and the conduct must be directly related to the appellate proceedings.
• Claim Construction: The district court's decision on claim construction and indefiniteness highlights the need for clear and convincing evidence to challenge patent validity.

FAQs

1. What were the main patents involved in the litigation between Almirall and Amneal?

• The main patents involved were U.S. Patent Nos. 9,161,926 and 9,517,219, related to Almirall's ACZONE Gel 7.5%.

2. Why did Almirall seek attorney fees and costs in the Federal Circuit?

• Almirall sought fees and costs incurred during the period from the end of settlement negotiations to the IPR trial date and for defending against Amneal's motion to dismiss, arguing that Amneal's continued pursuit of the IPR was unreasonable.

3. What was the outcome of the PTAB's decision on the '926 patent?

• The PTAB found that claims 1–6 of the '926 patent were not unpatentable.

4. How did the Federal Circuit rule on Amneal's motion to dismiss the appeal?

• The Federal Circuit granted Amneal's motion to dismiss the appeal but denied Almirall's request for attorney fees and costs.

5. What was the basis for Amneal's argument that the '219 patent was invalid due to indefiniteness?

• Amneal argued that the term "polymeric viscosity builder" (PVB) was indefinite because a POSA could not determine whether the PVB satisfied the concentration requirements described in the claims.

Cited Sources

1. AMNEAL PHARMACEUTICALS LLC LLC v. ALMIRALL LLC (2020) - Federal Circuit Court of Appeals.
2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ALMIRALL, INC., Plaintiff, v. AMNEAL PHARMACEUTICALS LLC, Defendant (2021) - GovInfo.
3. Amneal Pharmaceuticals LLC v. Almirall, LLC (Fed. Cir. 2020) - Patent Docs.
4. Almirall, LLC v. Amneal Pharmaceuticals LLC (Fed. Cir. 2022) - Patent Docs.
5. Almirall v. Amneal Pharmaceuticals – Negative Limitations II - National Law Review.